Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00424723
Status:
COMPLETED
Last Update Posted:
2010-08-12
First Post:
2007-01-18
Brief Title:
Pemetrexed in Patients With Advanced Neuroendocrine Tumors
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Study of Pemetrexed in Patients With Advanced Neuroendocrine Tumors
Status:
COMPLETED
Status Verified Date:
2010-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to find out what effects good and bad pemetrexed has on patients with advanced neuroendocrine tumors
Detailed Description:
1 cycle is equal to 21 days Every 21 days the following will be performed a review of the patients symptoms and medications physical exam blood tests vital signs and pemetrexed infusion
Every 3 cycles 9 weeks an assessment of disease extent by CT scan and a 24 hour urine collection if applicable will be performed
Before patients start receiving pemetrexed they will be given folic acid vitamin B12 and dexamethasone to help reduce the chance of significant side effects Dexamethasone will be taken the evening before the morning before and the evening after receiving pemetrexed Folic acid should be taken daily beginning 5-7 days before the first dose of pemetrexed and should be continued for three weeks after the last dose of pemetrexed Vitamin B12 will be given as an injection 1-2 weeks before the first dose of pemetrexed and once every 9 weeks until 3 weeks after the last dose of pemetrexed
Patients can continue to receive treatment with pemetrexed unless there is evidence that their tumor has grown or they are experiencing serious side effects
Immediately after the patient has completed the study they will be given a physical exam including vital signs a CT scan and blood tets The study staff will continue to monitor the patients health either by clinic visits or phone calls every three months for the remainder of your life
Every 3 cycles 9 weeks an assessment of disease extent by CT scan and a 24 hour urine collection if applicable will be performed
Before patients start receiving pemetrexed they will be given folic acid vitamin B12 and dexamethasone to help reduce the chance of significant side effects Dexamethasone will be taken the evening before the morning before and the evening after receiving pemetrexed Folic acid should be taken daily beginning 5-7 days before the first dose of pemetrexed and should be continued for three weeks after the last dose of pemetrexed Vitamin B12 will be given as an injection 1-2 weeks before the first dose of pemetrexed and once every 9 weeks until 3 weeks after the last dose of pemetrexed
Patients can continue to receive treatment with pemetrexed unless there is evidence that their tumor has grown or they are experiencing serious side effects
Immediately after the patient has completed the study they will be given a physical exam including vital signs a CT scan and blood tets The study staff will continue to monitor the patients health either by clinic visits or phone calls every three months for the remainder of your life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None